PCB Tutorial

Lesson 7 — Coding Medical Device, In-Vitro Diagnostic and Non-Medical Radiation Emitting Products

Non-Medical Radiation Emitting Products — Industry Codes 94 – 97

The product codes for non-medical radiation emitting products are similar to those for medical devices and in vitro diagnostic products. The codes are the responsibility of CDRH. These codes are part of the database that is used by the Product Code Builder application. Industry Codes 94, 95, 96 and 97 cover approximately 300 products. The three alpha characters represent the product classification code assigned by CDRH. The first alpha character of the product classification code goes under Product Class. However, this does not give the Product Class any specific meaning. The last two letters of the product classification code go under Product. Subclass and PIC are not used for these products; hyphens are entered in those two fields.

When you code these products, try searching for a keyword associated with the product. Often, this will quickly lead you to the correct Product Code.

Definitions of Non-Medical Radiation Emitting Products

There are four Industry Codes for non-medical radiation emitting products. They include:

Ionizing Non-Medical Devices and Components - Industry Code 94

Examples: Accelerator for non-medical use, High voltage vacuum tube, circuit breaker - automatic, television receiver or product containing a TV receiver

Light Emitting Non-Medical Device Products — Industry Code 95

Examples: Laser product for non-medical use, laser printers, CD players, sunlamp for non-medical use

Radio Frequency Emitting Products — Industry Code 96

Examples: Microwave heating products, microwave ovens

Sound Emitting Products — Industry Code 97

Examples: Ultrasound product for non-medical use, cordless phones

Subclasses

Subclasses are not used for non-medical radiation emitting products. Although Subclass is not used in this Industry, users and filers still need to transmit a hyphen "-" on the PIC field. The Product Code Builder Application will return a hyphen automatically.

Process Indicator Codes (PIC)

PICs are not used for Non-Medical Radiation Emitting products. Although Process Indicator Code is not used in this Industry, users and filers still need to transmit a hyphen "-" on the PIC field. The Product Code Builder Application will return a hyphen automatically.

Check Your Knowledge

1. Which of the following products would require a FDA Product Code?
2. Which of the following products would require a FDA Product Code?
3. Which of the following products would not require a FDA Product Code?

Code the Products

Now you will have a chance to practice coding some non-medical radiation emitting products. Below you will find eight product descriptions. Read the descriptions and then click on the PCB Application button below. This will take you to the Product Code Builder application.

Have paper and a pen or pencil handy. As you code each product, notate the product code result. When you're ready to check your answers, click the Tutorial button on the Taskbar. The Taskbar is located at the bottom of the screen. This will bring you back here. Caution: Don't click the Tutorial button in the Product Code Builder application; it will take you to the beginning of the Tutorial.

MERCURY VAPOR LAMP – METAL HALIDE (NON-MEDICAL)

Light Emitting Non-Device Products

No particular meaning

Not used

Not used

Metal Halide Lamp, Mercury Vapor Lamp

INDUSTRIAL DIELECTRIC HEATER

Radio Frequency Emitting Products

No particular meaning

Not used

Not used

Industrial Dielectric Heater

HIGH VOLTAGE VACUUM SWITCH

Ionizing Non-Medical Devices and Components

No particular meaning

Not used

Not used

High Voltage Vacuum Switches

CONSUMER MICROWAVE OVEN

Radio Frequency Emitting Products

No particular meaning

Not used

Not used

Consumer Microwave Oven for Food Preparation

LASER PRINTER

Light Emitting Non-Device Products

No particular meaning

Not used

Not used

Laser Printer, Utility/Peripheral Laser Products

COLOR TELEVISION RECEIVER FOR MEDICAL IMAGING

Ionizing Non-Medical Devices and Components

No particular meaning

Not used

Not used

TV Receiver for Medical Imaging

PORTABLE CD PLAYER

Light Emitting Non-Device Products

No particular meaning

Not used

Not used

CD, CD-Rom Player

Check your answers — Click on reveal code for each product description to reveal the correct product code. Compare it with the one you noted. Did you get the correct code? If not, determine which element was incorrect. You can go back to the Product Code Builder application and try again.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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